Drug product
Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
D-1415-2012
Product summary
- Event
- Event 62418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8994 Bottles
- Official record key
drug-enforcement:D-1415-2012
Official wording
Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Code information: a) SKU 34136-00; Lot #: SA2137SLA, SA2136SLB, Exp 05/13, SA2060SLB, Exp 02/14, SA2076SLB, SA2086SLC, SA2087SLA Exp 03/14, SA2131SLA, SA2135SLA, Exp 05/14 b) SKU 34135-00; Lot #: SA2086SLB, Exp 03/14 c) SKU 34111-00; Lot #: SA2086SLA, Exp 03/14, SA2122SLA, SA2123SLA, Exp 04/14
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Microbial contamination
Microbial Contamination